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CompletedNCT04206566PHASTERUpdated Dec 1, 2021

Pre-hospital Advanced Airway Management Studying Expedited Routines

An observational study in Emergency Medicine, Airway Management and Intubation, sponsored by Karolinska Institutet. Completed at 2 sites in Sweden. Per ClinicalTrials.gov, last updated 2021-12-01.

Sponsored by Karolinska Institutet · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
430
Sex
All
01

Study summary

In the Scandinavian and Swiss HEMS critical care teams, the prehospital tracheal intubations (TI) are performed by airway experts with high success rates and low rates of complications. Due to environmental conditions these are today frequently performed in-cabin before take-off. There are so far no published data on comparing outside and in-cabin TI under these circumstances.

This will therefore be the first prospective study comparing prehospital TIs outside or incabin, performed by airway experts.

Read the detailed description

Background Seriously ill or injured patients might require prehospital TI, which is a potentially lifesaving intervention. Performing TI in a prehospital context differ from the preconditions inhospital due to environmental and technical aspects and resources available (3). Today there is a consensus that prehospital critical care should at least be on the same standards as in-hospital care. The trend therefore has been towards more rigorous safety precautions introducing Standard Operating Procedures (SOP) including 360oaccess to patients with all equipment at close hand brought out from the helicopter or the ambulance and long challenge-response lists. This will shift focus towards adherence to SOPs instead of tailoring the sequence of procedures according to circumstances and patient needs. An experienced operator can plan and communicate appropriate actions from a risk-benefit perspective in a stressful situation. Prehospital interventions have to be time effective, especially where short on-scene times are preferable in time-critical conditions such as uncontrolled internal haemorrhage and traumatic brain injuries.

A recent Nordic multicentre study, PHAST, shows that emergency systems staffed with highly experienced anaesthetists can perform prehospital TI with high success rates, low incidence of complications and short on-scene times. Due to environmental factors, weather and light conditions in the Scandinavian countries, it is not always favourable to perform TI outside the helicopter or ambulance, with 360o -access. Technical aspects in-helicopter/in-ambulance such as access to better suctioning and stretcher positioning, can influence the operator's decision on where to perform the TI. Whether the location of the TI affects the outcome has not yet been studied. A recent experimental mannequin study, SPRINT, suggests that in-cabin intubations can offer equal to, or even better conditions than out of cabin and can shorten on-scene time. To investigate whether this applies to real life conditions, a prospective large-scale clinical study must be done.

Performing prehospital TI is dependent on a well-functioning team where the operator has an assistant backing up during the procedures. The assistants' level of airway experience and the teams' accumulated experience working together has not been studied earlier.

02

Conditions studied

  • Emergency Medicine
  • Airway Management
  • Intubation

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03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 430 is above the median of 353 across 714 observational studies indexed under Emergencies.

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Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All drug-assisted intubations performed at the participating HEMSorganizations between 01/01/2020 and 01/09/2021.

Inclusion criteria

  • Patients in need of prehospital drug-assisted intubation.

Exclusion criteria

Exclusion Criteria:

  • All cases where prehospital TI is performed without the use of any drugs.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
430 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. First pass success rate on prehospital tracheal intubation

    Successful intubation is defined as the endotracheal tube verified in the trachea. Prehospital intubations are performed outside the hospitals by ambulance helicopter personnel.

    Time frame: While handling the patient in need for tracheal intubation

Secondary outcomes

  1. Tracheal intubation performed outside or in-cabin (in helicopter or in ambulance)

    The location of the procedure

    Time frame: While handling the patient case

  2. Number of tracheal intubation attempts

    Time frame: While handling the patient case

  3. Perceived difficulty of tracheal intubation

    Measured on a numeric analogue scale

    Time frame: While handling the patient case

  4. Time to perform tracheal intubation

    Time from first passing teeth with laryngoscope to tube verification with ETCO2 and lung auscultation.

    Time frame: While handling the patient case

  5. Complications related to the drug assisted intubation

    Time frame: While handling the patient case

  6. Prehospital mortality

    Time frame: While handling the patient case

  7. Scene time 1

    Measured from entering patient zone (\<3 m) to starting to move the patient from the scene to the helicopter (if intubation in-ambulance, time from entering patient zone until starting to move the patient to the helicopter).

    Time frame: While handling the patient case

  8. Scene time 2

    Measured from entering patient zone (\<3 m) to declaring pilot can switch on helicopter motors.

    Time frame: While handling the patient case

  9. Ground time

    Mesaured from physician leaves helicopter to declaring pilot can switch on helicopter motors.

    Time frame: While handling the patient case

07

Study locations

2 sites
  • HEMS Dalarna
    Mora, Dalarna, Sweden
  • HEMS VGR
    Gothenburg, VästraGötaland, Sweden
08

References and documents

Individual participant data

Plan to share: Yes — All collected IPD

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04206566
Lead sponsor
Karolinska Institutet
Responsible party
Mikael Gellerfors (Head of Research & Development, Swedish Air Ambulance (SLA), Karolinska Institutet) — Principal investigator
First posted
Dec 20, 2019
Start date
Mar 1, 2020
Primary completion
Sep 1, 2021
Completion
Sep 1, 2021
Last update
Dec 1, 2021

Study contacts

Mikael Gellerfors
principal investigator · A PMI, Karolinska University Hospital, Stockholm

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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